(136 days)
The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.
The provided text describes a 510(k) premarket notification for a medical device called the ProToe™ EndoSorb™ Small Hammer Toe Pin. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a performance study. As such, the information you're asking for, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, is generally not part of a 510(k) summary for this type of device.
This device is a physical implant (an arthrodesis pin) made from a bioresorbable material. Its equivalence is based on its material, design, and intended use being similar to existing, legally marketed devices. Performance for such devices is typically evaluated through bench testing (e.g., mechanical strength, degradation properties) and possibly animal studies, but the detailed methodology and results demonstrating "acceptance criteria" through a specific "study" in the way you've outlined for AI or diagnostic devices are not typically presented in this format for this type of implantable device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document focuses on establishing substantial equivalence rather than reporting on a clinical or performance study with defined acceptance criteria and statistical outcomes for a novel device.
Here's what can be extracted, demonstrating the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (N/A) | Not applicable (N/A) |
| (No specific performance criteria or results are reported in this 510(k) summary for the ProToe™ EndoSorb™ Small Hammer Toe Pin. The submission focuses on substantial equivalence to predicate devices based on similar indications for use, materials, and technological characteristics.) |
2. Sample size used for the test set and the data provenance:
- N/A. No clinical or performance study with a "test set" is described for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical or performance study requiring expert ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical or performance study requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is an arthrodesis pin, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is an arthrodesis pin, not an algorithm. Standalone performance as described is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No type of "ground truth" as relevant to diagnostic performance is mentioned. The equivalence is based on physical characteristics and intended use.
8. The sample size for the training set:
- N/A. No training set is applicable for this physical implant device.
9. How the ground truth for the training set was established:
- N/A. No training set or ground truth establishment relevant to an AI or diagnostic context is applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.